Equillium Announces Feedback from the U.S. Food and Drug Administration
Equillium, Inc. (EQ)
Last equillium, inc. earnings: 3/26 04:07 pm
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Source: Business Wire
LA JOLLA, Calif.--(BUSINESS WIRE)--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that the company has received feedback from its Type D meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for Accelerated Approval, as well as the company’s filing for Breakthrough Therapy designation for itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD).The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data. The FDA highlighted its attention to achieving response outcomes at Day 29, per existing FDA guidance; however, the FDA did indicate openness to evaluating other endpoints, including longer term outcomes, provided independent data supports the validity of such endpoints.“We are cle
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News
- Equillium Announces Multiple Poster Presentations Highlighting EQ504 at the Annual Meeting of The American Association of Immunologists [Yahoo! Finance]Yahoo! Finance
- Equillium Announces Multiple Poster Presentations Highlighting EQ504 at the Annual Meeting of The American Association of ImmunologistsBusiness Wire
- Equillium Announces New Aryl Hydrocarbon Receptor Modulator Program EQ504 [Yahoo! Finance]Yahoo! Finance
- Equillium Announces New Aryl Hydrocarbon Receptor Modulator Program EQ504Business Wire
- Equillium, Inc. (NASDAQ: EQ) was downgraded by analysts at Leerink Partnrs from a "strong-buy" rating to a "hold" rating.MarketBeat
EQ
Earnings
- 3/27/25 - Beat
EQ
Sec Filings
- 6/13/25 - Form 8-K
- 6/12/25 - Form 144
- 5/23/25 - Form 4
- EQ's page on the SEC website